Recall Z-2301-2012— Nellcor Puritan Bennett Inc. (dba Covidien LP)
Class II · Terminated
Class II FDA medical device recall by Nellcor Puritan Bennett Inc. (dba Covidien LP), initiated 2012-08-01, terminated 2013-09-06. It names 2 FDA 510(k) clearances: K030697, K973297. Product: DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containing DGPHP RFA High-Power single use grounding pads) The product is used during ablation surgical procedures.. Reason: Covidien is conducting a recall of various production lots of DGHP RFA High Power single use grounding pads and Cool-tip RFA Electrode Kits due to the potential for foil degradation on the DGP-HP single use grounding pad which may result in an electrical burn to the patient at the application site..
- Recalling firm
- Nellcor Puritan Bennett Inc. (dba Covidien LP)
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-08-01
- Terminated
- 2013-09-06
- Firm location
- Boulder, CO, United States
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containing DGPHP RFA High-Power single use grounding pads) The product is used during ablation surgical procedures.
Reason for recall
Covidien is conducting a recall of various production lots of DGHP RFA High Power single use grounding pads and Cool-tip RFA Electrode Kits due to the potential for foil degradation on the DGP-HP single use grounding pad which may result in an electrical burn to the patient at the application site.
Data sourced from openFDA. This site is unofficial and independent of the FDA.